Expansion with a new production line with enhanced capacity
With an additional fully automated fill & finish line (250L), coupled to a fully automated freeze-dryer, we aim to achieve and maintain the same level of service and quality requirements as we have for our current production line (50L). For a quick overview of the capabilities of our new production line see below.
EMA & US-FDA certified facility
Liquid & freeze dried products
Also suited for (larger scale) clinical trial programs
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Automated filling line in ’tunnel’ design + RABS technology
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250L + 10 m² freeze drier
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Expansion to our current available aseptic production lines
Filling machine (Groninger)
- Vial washing machine
- Depyrogenisation oven
- Filling machine (incl 100% IPC + stoppering)
- Capping machine
Freeze dryer (HOF)
- 10 m²
- Automated loading / unloading
- 7 shelves
Single use materials (pre sterilized)
Features
- Up to 12 million vials / year
- Liquid products: 30L up to 250L / batch
- Freeze dried products: 30L up to 200L / batch
- Speed: up to 200 vials / min
- Vial sizes: 2 RDIN up to 50 ml vials
160 batches / year; 4 batches / week
Maximum batch sizes
Compounding volumes: 200L – 250L
Freeze dryer: 10 m² (7 shelves)
| Vial Size | Liquid product | Lyophilized product |
| 250L/batch | 200L/batch | |
| 2 RDIN | 74.800 | 44.000 |
| 6 RDIN | 41.600 – 74.800 | 23.000 |
| 10 RDIN | 25.000 – 74.800 | 19.200 |
| 20 RDIN | 12.500 – 65.500 | 12.000 |
| 25 RDIN | 10.000 – 56.100 | 12.000 |
| 50 mL | 5.000 – 46.800 | 5.700 |
Minimum batch sizes
Compounding volume as of 30L
Freeze drying as of 3 shelves
| Vial Size | Liquid product | Lyophilized product |
| 30L/batch | 30L/batch | |
| 2 RDIN | 15.000 | 18.900 |
| 6 RDIN | 5.000 | 9.800 |
| 10 RDIN | 3.000 | 8.200 |
| 20 RDIN | 1.500 | 5.100 |
| 25 RDIN | 1.200 | 5.100 |
| 50 mL | 600 | 2.400 |
